Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among adolescents who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Refrigerator: Between 2C and 8C (36F and 46F)A carton of 10 single-dose vials may take up to 2 hours to thaw at this temperature. a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. You may also be given an option to enroll in v-safe. The expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) . Vials stored at -25C to -15C (-13F to 5F) for up to 2 weeks may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). La vacuna contra el COVID-19 de Pfizer-BioNTech para nios de 5 a 11 aos de edad se administra como una serie primaria de dos dosis, con 3 semanas de diferencia, pero es una dosis ms baja (10. Pfizer-BioNTech COVID-19 VaccineDose 1N=2291n (%), Pfizer-BioNTech COVID-19 VaccineDose 2N=2098n (%). Shelf-life expiration dates have been extended multiple times as additional data becomes available. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.4MB) and the Letter of Authorization (PDF, 375KB). Check Lot. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.10. Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description (13)]. Theres a place for you in the Academy no matter where you are in your career. COVID-19 vaccines authorized under an emergency use authorization do not have fixed expiration dates, and expiration dates may be Please refer to the table on this page for the new updates. Therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the Agency. Of the total number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) were 75 years of age and older. Should you decide not to receive any of these vaccines, it will not change your standard medical care. A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age with certain kinds of immunocompromise. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. FDA granted this extension following a thorough review of data submitted by Eli Lilly. After the first dose has been withdrawn, the vial should be held between 2C to 25C (36F to 77F). However, when enforcement discretion is used for medical product dating extensions, MCMs are not covered under applicable Public Readiness and Emergency Preparedness (PREP) Act liability protections. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the United States. Thank you for using the Janssen COVID-19 Vaccine expiry checker. The QR code on the label is a link to the EUA factsheet. The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer.Thawed vaccine cannot be refrozen. Solicited Local and Systemic Adverse Reactions. States may contact their MCM Specialist or email preparedness@cdc.gov or sns.ops@cdc.gov to confirm the new extended dates for their antiviral drug inventories eligible for extension. Marketing. Information to include: The following steps are highlighted to provide the necessary information for safety tracking: There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. From an independent report (Kamar N, Abravanel F, Marion O, et al. Know your Vaccine Products and Storage Needs, Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States, Long-term Follow-up Care for Childhood, Adolescent and Young Adult Cancer Survivors, Roadmap for Care of Cancer Survivors: Joint Report Updates Recommendations, American Academy of Pediatrics Offers Guidance for Caring and Treatment of Long-Term Cancer Survivors, Childhood Cancer Survivors: What to Expect After Treatment, Transition Plan: Advancing Child Health in the Biden-Harris Administration, Childrens Health Care Coverage Fact Sheets, Prep- Pediatric Review and Education Programs, Practice Research in the Office Setting (PROS), Pediatrician Life and Career Experience Study (PLACES), CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov), Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov), Fact Sheet for Health Care Providers Administering Vaccine (5 11 years), CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary, Pfizer-BioNTech COVID-19 Vaccine (Gray Cap) Age 12 and Over, Fact Sheet for Health Care Providers Administering Vaccine (12 years and up), FDA Fact Sheet for Health Care Providers Administering Vaccine (5 through 11 years), BIVALENT (Original and Omicron), CDC US COVID-19 Vaccine Product Information, CDC Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines, Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Moderna COVID-19 Vaccine Storage and Handling Summary, Fact Sheet for Health Care Providers Administering Vaccine (6 months 5 years), Fact Sheet for Health Care Providers Administering Vaccine (6 11 years). The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials with purple caps; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. The duration of protection against COVID-19 is currently unknown. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. As required by the EUA, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2C to 8C (36F to 46F) in the original carton to protect from light. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. TPOXX supplied by the, Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), Public Readiness and Emergency Preparedness Act of 2005 (PREP Act). L For the most recent Fact Sheet, please see www.cvdvaccine.com. In a similar analysis, in participants 56 years of age and older (Pfizer-BioNTech COVID-19 Vaccine = 7,960, placebo = 7,934), serious adverse events were reported by 0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. Storage for longer than 10 weeks requires an Ultra Cold freezer. Exp Date: 01/2022 . October 21, 2020:FDA is alerting civilian health care professionals and emergency responders of 1 pralidoxime chloride and 5 CANA (diazepam) auto-injector lots for which the new use date has passed; however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions. The site is secure. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. However, before FDA can issue an EUA, a specific type of determination must be in place, the HHS Secretary must issue a declaration to justify the issuance of the EUA, the section 564 statutory criteria for issuing an EUA must be met, and FDA must determine that it is safe to use the product beyond its labeled expiration date. HOW ARE COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT RELATED? August 23, 2021. Do NOT use vaccine if the expiration date or beyond-use time has passed. endobj
Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. } c Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. These vaccines do not contain SARS-CoV-2 and cannot give you COVID-19. The vaccine efficacy information is presented in Table 8. For the most recent Fact Sheet, please see www.cvdvaccine.com. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. FDA issued this EUA, based on Pfizer-BioNTech's request and submitted data. Some vaccine storage conditions are associated with beyond-use dates and times. WHAT YOU NEED TO KNOW BEFORE YOU GET ANY OF THESE VACCINES. For more information about CICP regarding the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19, visit www.hrsa.gov/cicp/, email cicp@hrsa.gov, or call: 1-855-266-2427. Adverse reactions following administration of the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, lymphadenopathy, decreased appetite, rash, and pain in extremity (see Full EUA Prescribing Information). April 24, 2019: FDA published a final guidance for government public health and emergency response stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. NOTE: Expiration dates extension does NOT apply to vials dated July 2021 and earlier. helix-grid.hydrated, helix-mega-menu.hydrated, helix-layout-container.hydrated, helix-core-grid.hydrated, helix-core-header.hydrated, helix-core-page-break.hydrated, helix-core-card-group.hydrated, helix-core-footer.hydrated, helix-core-band.hydrated { This authorization is based on safety and effectiveness data in this age group and adults. A carton of 10 vials may take up to 2 hours to thaw in the refrigerator [2C to 8C (35F to 46F)]. Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. For additional information about Emergency Use Authorization visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine: Side effects that have been reported with these vaccines include: These may not be all the possible side effects of these vaccines. Also see: Expiration date extensions of certain lots of doxycycline hyclate. Providers should track these time frames. Vaccine may be thawed in the refrigerator or at room temperature. Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with purple caps arrive in thermal containers with dry ice. Two vaccines can be given in one appointment. The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system. Copyright 2023 American Academy of Pediatrics. COVID-19 disease is caused by a coronavirus called SARS-CoV-2. To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number, and original labeled expiration date. Don't worry. First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*, Pfizer-BioNTech COVID-19 VaccineN=18,198 Casesn1Surveillance Time (n2#), Placebo N=18,325 Casesn1Surveillance Time (n2#), First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection, Pfizer-BioNTech COVID-19 VaccineN=19,965Casesn1Surveillance Time (n2#), PlaceboN=20,172Casesn1Surveillance Time (n2#). Frozen vials transported at -25C to -15C (-13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F).